Note: Due to the events this week related to Congress, the FDA and the Kennedy, Burr, Roberts draft bill, the editorial will be on a different topic than what was scheduled. We will pick up with Part III of Quality Assurance in Compounding next week.
Editorial: The Shell Game
Which FDA is speaking? The U.S. Food and Drug Administration (FDA) is charged with one of the highest responsibilities of any governmental agency-the safety of the nation's commercial food and drug supply. The FDA approaches SOME of this responsibility to the "letter of the law" and enforces these standards stringently with little or no tolerance as they are the FINAL WORD and as if they never make mistakes.
On the other side, the Agency has a track record of poor performance and errors in judgment. If a pharmacist receives a visit from the FDA and is issued a "483," they may spend tens or hundreds of thousands of dollars defending themselves for questionable actions brought upon them by the FDA. However, the FDA personnel are not penalized at all if things they say and do are not correct, but, instead, may receive a promotion. It seems the FDA personnel have nothing to lose when they make poor decisions.
Many of the press releases issued by the FDA are actually fraudulent, (Fraud is defined as deceit, misrepresentation, trickery; specifically, intentional perversion of truth in order to induce another to part with something of value or to surrender a legal right.) such as the one this week. They are fraudulent because they do not present the truth, or the whole truth. In addition, the character of some of the leadership in the FDA has been shown to be questionable and even corrupt.
In working with many personnel at the FDA over the years, some of my former graduate students are in positions at the FDA. Knowing of their desire to do what is right, it may be time for Congress to make some changes at the FDA.
The FDA has gone unchallenged far too long. The Agency has continued to expand their power base into new areas even though they are not doing a very good job at what they are supposed to be doing now. Why, then, do they want more power to control pharmaceutical compounding? I think part of the reason could be that it makes for easy media coverage to falsely portray to citizens of the U.S. that the FDA is doing their job. In reality, they may be sitting on many decisions that need to be made regarding removing some commercial products from the marketplace and may be approving new drugs prematurely. However, a significant amount of their funding for the FDA comes from the pharmaceutical industry so it appears there may be a conflict of interest (as has been shown recently).
From what is currently happening, one cannot really trust the FDA press releases and decisions because we cannot be assured they are truthful and in the best interest of the people they are supposed to serve. Maybe its time to reign in some of the power of the FDA and make the Agency smaller and more accountable so they can concentrate their efforts and do a better, more truthful job!
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief
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